Kornimate/medical-research-clean huggingface dataset:
use of spy imaging system to minimize fistulas after hypopharyngeal reconstruction

Conditions: Squamous Cell Carcinoma; Pharyngocutaneous Fistula

Summary: investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (pcf). a pcf is a leak in the tube in the throat that helps with breathing and digesting food. the imaging is called the spy fluorescence system. this system can identify tissue that is not receiving enough blood. the spy fluorescence system uses a special dye, called indocyanine green (icg) to better see the tissues that are not receiving enough blood. when tissue does not receive enough blood, it can lead to infection. infection of tissue in this area of the throat can lead to pcf. the imaging takes about 1 minute and is performed in the operating room during surgery. for this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the spy fluorescence system to have decreased blood flow. they will then continue with the rest of the surgery as usual. the investigators will monitor participants as they recover from surgery to identify any complications that may occur. for this research they are interested in complications during the first month after surgery since this is when pcf usually happens. investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.

our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using indocyanine green (icg) angiography. in an observational study of 41 patients who underwent salvage tl with onlay free flap reconstruction, 7 (17%) patients developed pcf. intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. in patients with ingress \ 15. of note, in patients with ingress \<15, there was no intervention performed as this was an observational study.

Eligibility criteria:
inclusion criteria: 1. prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage ii-iv) 2. prior treatment with radiation +/- chemotherapy 3. presence of local recurrence of disease, radiation necrosis or an incompetent larynx 4. 18 years or older. 5. ability to understand and sign informed consent exclusion criteria: 1. iodine and shellfish allergy 2. contraindication to surgery under general anesthesia 3. anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. this may only be determined at the time of surgery 4. pregnancy or lactation. 5. patients residing in prison.

Keywords: squamous cell carcinoma hypopharynx squamous cell carcinoma larynx spy fluorescence imaging system
stress reactivity study in adolescents

Conditions: Stress; Eating Behavior

Summary: the goal of this study was to examine the glucocorticoid and behavioral responses to a psychological stressor in obese african-american and non-latino white adolescents. participants were exposed to the trier social stress test (tsst) and a control condition on separate days. immediately following each condition, participants were provided with snacks to eat at their leisure. reactivity was assessed via salivary cortisol and alpha-amylase area under the curve (auc), and adolescents were categorized as high or low reactors.

in the united states, pediatric obesity has more than tripled in the last 30 years, particularly among certain racial/ethnic groups including african-americans. this disparity is partially attributable to greater exposure to psychological stress reported in this group (relative to non-latino whites). chronic psychological stress leads to weight gain directly through prolonged exposure to biological stress mediators such as cortisol and indirectly through behavioral pathways involving cortisol-induced increases in food consumption. an exciting arena of scientific advancements is focusing on identifying the specific pathways through which chronic stress influences eating behavior with emerging evidence to suggest that food intake, which is commonly increased during periods of stress, may serve as one key mechanism linking stress and obesity, particularly in african-american youth who are disproportionately exposed to chronic stress and have greater access to, and consumption of, energy-dense palatable foods. it is critical to advance understanding of the interplay between stress and food intake in understanding racial/ethnic disparities in pediatric obesity because stress eating represents a modifiable health behavior. that is, increased food intake during periods of elevated stress can be targeted for intervention in ways that may ameliorate the deleterious effects of stress on obesity risk. this project investigated the role of stress eating as a pathway linking chronic stress and obesity in african-american and non-latino white adolescents.

Eligibility criteria:
inclusion criteria: * overweight and obese adolescents ages 14- 19 years exclusion criteria: * currently pregnant * had been enrolled in a weight loss program in the last 6 months * were current smokers (e.g., tobacco, marijuana, vaping) * were diagnosed with a mental health condition (e.g, depression) * were diagnosed with a chronic condition known to affect weight, appetite, blood glucose or insulin levels (e.g., diabetes) * were taking medications known to affect metabolic processes (e.g., growth hormone, ritalin, metformin, etc) * had food allergies, intolerances, or other dietary restrictions

Keywords: trier social stress test
study of cpmp (precusor z) to treat molybdenum cofactor deficiency (mocd) type a

Conditions: Molybdenum Cofactor Deficiency Type A

Summary: molybdenum cofactor deficiency type a (mocd) is a very rare autosomal recessive disorder that is essentially fatal early in life. naturally occurring cpmp is present in the body of all healthy normal individuals. it is processed to molybdopterin, which is further processed to molybdenum cofactor. molybdenum cofactor is essential for the function of important enzymes. there is currently no treatment for mocd, and affected infants develop severe neurological damage which often results in infant death. this study is the first clinical trial to investigate the potential of replacement of cpmp to infants with mocd type a. the safety, tolerability, and pharmacodynamics of daily intravenous administration of cpmp over 3 months will be determined.


Eligibility criteria:
inclusion criteria: * neonate or infant, less then 6 weeks at the time of diagnosis, age less than 8 weeks at start of treatment with the study medication. it is important to diagnose the condition and initiate treatment as soon after birth as possible. * documented diagnosis of molybdenum cofactor deficiency (mocd) type a based on the absence of cpmp and the presence of sulfite and s-sulfocysteine in the urine, absence of urothione in the urine and genetic analysis showing a mutation in the mocs1 gene * a parent or legal guardian voluntarily provided written informed consent to participate in the study and comply with study procedures. * approval of the study protocol by the local he / irb and government or regulatory authorities (if applicable) exclusion criteria: * mocd type b (mocs2 mutation) or type c (gephyrin gene mutation) * sulfite oxidase deficiency * patients older than 6 weeks at the time of diagnosis
clinical trial for the validation of ar based neuronavigation system

Conditions: Brain Neoplasms; Cerebral Aneurysm; Cerebral Arteriovenous Malformation; Navigation, Spatial

Summary: the goal of this clinical trial is to test augmented reality (ar) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. the main questions it aims to answer are: • ar based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system. participants will participate the study after informed consent. when participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed ar based neuronavigation system. surgeon will plan and conduct surgery based on only conventional navigation system, but 3d errors at several selected points between two types of navigation will be measured and analyzed.

being developed ar navigation were reported in our following papers: 1. dho ys, et al., development of an inside-out augmented reality technique for neurosurgical navigation. neurosurgical focus. 2021 aug 1;51(2):e21. (doi.org/10.3171/2021.5.focus21184) 2. moon hc, et al., navigation of frameless fixation for gamma knife radiosurgery using fixed augmented reality. scientific reports. 2022 mar 16;12(1):1-0. (doi.org/10.3171/2021.5.focus21184) this study aims to evaluate the accuracy of anatomical localization of a newly developed augmented reality-based neurosurgery navigation. after 3-dimensional (3d) modeling of the brain of a patient with brain tumor or cerebral vascular disease through 3d image segmentation extraction and modeling, the augmented reality (ar)-based navigation developed by this research team can be used with a commercially available visualization device, such as ipad, iphone, and hololens2, to evaluate the accuracy. the ar-based navigation obtained approval from the ministry of food and drug safety of republic of korea (class 2 medical device) in february 2022. through this clinical tria that compare accuracy with existing conventional intraoperative neuronavigation system, we will evaluate whether it shows equivalent performance to replace the existing navigation.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older who underwent mri or ct scan due to brain tumor or cerebrovascular disease * adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease exclusion criteria: * cases where application of navigation is not necessary according to the judgment of the researcher or surgeon * when the patient or guardian does not agree * patients with anatomical deformation due to previous surgery or requiring emergency surgery

Keywords: augmented reality neuronavigation brain neoplasms cerebral arteriovenous malformation cerebral aneurysm
lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis

Conditions: HepatoCellular Carcinoma; Portal Vein Tumor Thrombosis

Summary: this is a phase i/ii dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.

protocol number: tlctlc388a1008 primary objective: to evaluate the safety and tolerability, including maximum tolerated dose (mtd) and dose-limiting toxicity (dlt), of lipotecan based concurrent chemoradiotherapy (ccrt) in patients with hepatocellular carcinoma (hcc) and portal vein tumor thrombosis (pvtt) unsuitable for local treatment. secondary objective: the secondary objective is to explore the efficacy of lipotecan based ccrt in patients with hcc and pvtt and the effect on quality of life.

Eligibility criteria:
inclusion criteria: 1. patients will be males or females * ≥20 years of age in taiwan * ≥18 years old in china 2. patients with histologically confirmed hcc or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical hcc image of contrast enhanced ct scan or mri. if the image characteristic is not typical of hcc, another contrast enhanced image modality should be confirmed for diagnosis. 3. patients with pvtt (bclc stage c) who are not suitable for local therapies 4. patients with a measureable targeting lesion 5. patients with an anticipated residual life expectancy ≥3 months 6. patients who have adequate organ function 7. patients with eastern cooperative oncology group (ecog) performance status ≤2 8. patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment 9. patients willing and able to comply with the study procedures and to sign a written icf exclusion criteria: 1. patients with infiltrative type hcc 2. patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis 3. patients with a history of west haven criteria grade iii-iv hepatic encephalopathy or ascites 4. patients with a history of other malignancy except primary hcc within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma 5. patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning 6. patients with an inadequately defined hepatic tumor margin for rt planning on mri or ct that may impact treatment or safety based on investigator's judgment 7. patients who have experienced significant allergy or hypersensitivity to the contrast medium for ct or mri that makes it unsafe to perform the delineation for rt planning 8. patients with a history of liver transplantation 9. patients with a significant concurrent disease

Keywords: hepatocellular carcinoma portal vein tumor thrombosis tlc388 chemoradiotherapy lipotecan
optimized magnetic resonance brachytherapy (mr bt) in cervix cancer

Conditions: Cervix Cancer

Summary: patients with cervix cancer usually require external radiation given to the whole pelvis then an internal radiation boost, also called brachytherapy, to treat any remaining tumour. standard brachytherapy has been used successfully for many years, but does not take into account differences in the shape of the tumour or normal structures between patients. this study aims to implement individualized -optimized- brachytherapy, based on international recommendations. mr scanning with the intra-uterine applicator in place allows improved identification of residual tumour and normal structures, allowing brachytherapy to be individualized for each patient with the aim to reduce side-effects and improve outcome. additionally, repeating mr scans during brachytherapy treatment will allow further assessment on motion of the applicator during treatment and the effect on radiation dose. sexual health assessments aim to identify the relationship between sexual health and treatment effects.

pre-treatment: prior to examination under anaesthesia and placement of the intra-uterine applicator, in addition to standard assessment of treatment toxicity, the patient may complete an optional sexual health assessment taking approximately 15 minutes. following standard insertion of the intra-uterine applicator under general anaesthetic and planning mri scan, there is an optional additional mri scan taking an extra 30 minutes this extra scan will not affect the commencement of treatment planning as images from the planning scan will be transferred to the treatment planning system as soon as they are obtained. from the mri planning scan, target and specific normal structures are contoured. an individual bt plan will be derived based on a standard plan to deliver dose within specified dose volume constraints. during treatment: during inpatient bt optional mri scans, each taking 15 minutes will be obtained in the period between treatment pulses once during each 24 hours of admission. the information from the additional mri scans will not be used to alter or influence treatment. follow-up: standard follow-up procedures will be followed, with the optional addition of the sexual health evaluation at each visit.

Eligibility criteria:
inclusion criteria: * age over 18 years * ecog performance status 0-2 * histological confirmed carcinoma cervix * decision to treat with ebrt (+/- concurrent chemotherapy), and pdr bt * ability to comply with study protocol * patient informed consent exclusion criteria: * unable to or unwilling to give informed consent * not suitable for intra-uterine brachytherapy * previous treatment for pelvic malignancy * previous pelvic radiotherapy * serious claustrophobia * previous history of metallic injury to the eye * non-removable implants contraindicated for mri * cardiac pacemaker * other contraindication to mri -pregnancy, lactation or child-bearing potential without adequate contraception -

Keywords: intra-uterine brachytherapy cervix cancer patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
multiparametric telemonitoring in elderly people with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) determines an important risk of disability and disease-related need of care. selected interventions were able to reduce the number and the severity of exacerbations. telemedicine has also been proposed for this purpose. current evidences, however, are scant. the investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.

all patients performed a simple spirometry that was carried out using a stead-wells bell spirometer (biomedin, padua, italy). upon provision of informed consent, patients in the telemonitoring group were invited to a session during which they were instructed on how to wear the wristband and to operate the cellular telephone. a study physician was available on call during office hours to assist patients needing further instructions. a technician was also available in order to solve ingoing hardware problems. all participants were also clinically evaluated at baseline and received a multi-dimensional assessment including: activities of daily living scale (adl), instrumental activities of daily living scale (iadl), mini-mental state examination (mmse) test. these are well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status. patients in both groups were followed up for 9 months, during this period they attended the standard schedule of clinical controls. for patients in the sweetage group, the parameters received were evaluated daily by a study physician. in case of abnormal readings, the physician systematically contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. in this event, the patient's adherence to her/his therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. otherwise, a diagnosis of exacerbation was made and, on the basis of its severity, an outpatient clinical assessment (for mild exacerbations) or a hospital admission was scheduled. the outcome measures of these study were: number of exacerbations (defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications, and number of hospital admissions.

Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease stage ii-iii (gold classification) exclusion criteria: * cognitive impairment precluding the use of the experimental device.
coq10 in statin-associated asthenia

Conditions: Hypercholesterolemia; Physical Performance

Summary: this was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effects of supplementation with coq10 phytosome on physical performance in older adults with self-reported statin-associated asthenia.


Eligibility criteria:
inclusion criteria: * 65-80 years of age * treatment for \>6 months with statin monotherapy (i.e. enrolled individuals were asked to be on the same statin at the same dosage for \>6 months) * statin-associated asthenia for \>3 months exclusion criteria: * serious or disabling diseases (e.g. severe organ failure, malignancy or dementia) * orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia * obesity (body mass index (bmi)\> 30 kg/m2) * known gastrointestinal disorders potentially affecting the absorption of coq10

Keywords: statin asthenia coenzyme q10
schedule follow up visit 5-7 yr

Conditions: Heart Transplantation

Summary: the major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of csa compared to standard immunosuppressive regimen including csa on primary and secondary endpoints investigated in the schedule (nct01266148) main study.

this protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month schedule (nct01266148) study and the following 3-year follow-up examination/visit. the aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (certican®) and early elimination of cyclosporine (csa), compared to standard immunosuppressive regimen including csa, on renal and heart function. during the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original schedule study). study code of schedule, the core study: crad001ano02 (eudract no.: 2009-013074-41)

Eligibility criteria:
inclusion criteria: * patients who participated in the schedule 12-month main study, and who completed the 3 year follow-up visit * patients who are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study * obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination. exclusion criteria: * patients with a retransplanted heart since the original schedule study

Keywords: allograft rejection xenograft rejection host vs graft disease transplant
blood-aqueous barrier integrity in eyes undergoing intravitreal bevacizumab therapy to treat neovascular amd

Conditions: Exudative Age-related Macular Degeneration

Summary: the aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * active amd-associated choroidal neovascularization (cnv) confirmed with fluorescein angiography (fa) and optical coherence tomography (oct) exclusion criteria: * history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (vegf) injections